At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
CoreValve aortic valvedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CoreValve® ADVANCE Direct Aortic Study
In Brief
An observational study evaluating CoreValve aortic valve for Aortic Stenosis and Valvular Heart Disease. Completed, enrolled 100 participants across 9 sites in 6 countries.
Detailed Summary
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis, Valvular Heart Disease
CountriesCzechia, France, Germany, Italy, Netherlands, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartSep 2012
Primary CompletionApr 2014
Study CompletionAug 2015
TodayJul 2026
First PostedAug 31, 2012
Enrollment StartSep 1, 2012
Primary CompletionApr 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.8 years ago
Interventions
CoreValve aortic valvedevice
Implantation of CoreValve aortic valve via direct aortic approach